Drug administration controller
A drug administration controller has a sensor that generates a sensor signal to a physiological measurement device, which measures a physiological parameter in response. A control output responsive to the physiological parameter or a metric derived from the physiological parameter causes a drug administration device to affect the treatment of a person, such as by initiating, pausing, halting or adjusting the dosage of drugs administered to the person.
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The present application claims priority benefit under 35 U.S.C. §119(e) to U.S. Provisional Patent Application Ser. No. 60/759,673, filed Jan. 17, 2006, entitled Drug Administration Controller, and Ser. No. 60/764,946, filed Feb. 2, 2006, entitled Drug Administration Controller, which are both incorporated by reference herein.
BACKGROUND OF THE INVENTIONPhysiological measurement systems employed in healthcare often feature visual and audible alarm mechanisms that alert a caregiver when a patient's vital signs are outside of predetermined limits. For example, a pulse oximeter, which measures the oxygen saturation level of arterial blood, indicates oxygen supply. A typical pulse oximetry system has a sensor that provides a signal output to a pulse oximeter monitor. The sensor has an emitter configured with both red and infrared LEDs that project light through a fleshy medium to a detector so as to determine the ratio of oxygenated and deoxygenated hemoglobin light absorption. The monitor has a signal processor, a display and an alarm. The signal processor inputs the conditioned and digitized sensor signal and calculates oxygen saturation (SpO2) along with pulse rate (PR), as is well-known in the art. The display provides a numerical readout of a patient's oxygen saturation and pulse rate. The alarm provides an audible indication when oxygen saturation or pulse rate are outside of predetermined limits.
Another pulse oximetry parameter is perfusion index (PI). PI is a measure of perfusion at the pulse oximetry sensor site comparing the pulsatile (AC) signal to the non-pulsatile (DC) signal, expressed as a percentage ratio. An example is the PI Delta Alarm™ feature of the Radical 7™ Pulse CO-Oximeter™ available from Masimo Corporation, Irvine, Calif., which alerts clinicians to specified changes in PI. In particular, PI Delta indicates if PI at a monitored site decreases by a specific level (delta) over a specified window of time, with both variables selectable by the user within predetermined ranges.
Tracking a series of desaturations over time is one metric that is derived from SpO2 that is well-known in the art. See, e.g., Farney, Robert J., Jensen, Robert L.; Ear Oximetry to Detect Apnea and Differentiate Rapid Eye Movement (REM) and Non-REM (NREM) Sleep: Screening for the Sleep Apnea Syndrome; Chest; April 1986; pages 533-539, incorporated by reference herein. Traditional high and low SpO2 alarm limits alert clinicians to saturation levels that exceed user-selected thresholds, and these thresholds are typically established at a considerable change from the patients' baseline saturation level. However, in select patient populations, substantial desaturation events that exceed a typical low alarm limit threshold may be preceded by a cycle of transient desaturations over a limited timeframe. The ability to alert clinicians to a cycle of these smaller desaturations provides an earlier indication of a potential significant decline in the patient's status and the need for more focused monitoring and/or a change in treatment. An example is the Desat Index Alarm™ feature of the Radical 7™, mentioned above, which enables clinicians to detect an increasing quantity of smaller desaturations that may precede declining respiratory status. Desat Index is a measure responsive to patients that experience a specific number of desaturations beyond a defined level from the patient's baseline saturation over a specific window of time, with each of these variables selectable by the user within predetermined ranges.
A physiological parameter that can be measured in addition to, or in lieu of, SpO2 is respiration rate (RR). A respiration rate monitor utilizes a body sound sensor with piezoelectric membranes particularly suited for the capture of acoustic waves and the conversion thereof into electric signals. To detect body sound, the piezoelectric membranes are used as mechano-electric transducers that are temporarily polarized when subject to a physical force, such as when subjected to the mechanical stress caused by the acoustic waves coming from the inside of a patient's body. The body sound sensor is typically attached to the suprasternal notch or at the lateral neck near the pharynx so as to detect tracheal sounds. A sound sensor is described in U.S. Pat. No. 6,661,161 entitled Piezoelectric Biological Sound Monitor With Printed Circuit Board, incorporated by reference herein. A respiration rate monitor is described in U.S. patent application Ser. No. 11/547,570 entitled Non-Invasive Monitoring of Respiratory Rate, Heart Rate and Apnea, incorporated by reference herein.
SUMMARY OF THE INVENTIONConventional patient monitors give insufficient advance warning of deteriorating patient health or the onset of a potentially serious physiological condition. Advantageously, a drug administration controller is responsive to one or more physiological parameters in addition to, or in lieu of, SpO2 and PR, such as carboxyhemoglobin (HbCO), methemoglobin (HbMet), perfusion index (PI) and respiration rate (RR), to name a few. Further, a drug administration controller is advantageously responsive not only to preset parameter limits but also to various metrics derived from measured physiological parameters, such as trends, patterns and variability, alone or in combination, to name a few. As such, a drug administration controller is adapted to pausing or otherwise affecting drug administration based upon one or more physiological parameters and one or more metrics. Parameter variability is described with respect to PI in U.S. patent application Ser. No. 11/094,813 entitled Physiological Assessment System, incorporated by reference herein.
As an example, a drug administration controller may be responsive to changes in HbMet. Gaseous nitric oxide (NO) is increasingly recognized as an effective bacteriostatic or bacteriocidal agent. NO, however, can toxically increase HbMet.
A drug administration controller may be responsive to changes in perfusion index, such as measured by PI Delta, described above. PI may change dramatically in response to sympathetic changes in vasoconstriction or vasodilation of peripheral vessels caused by anesthesia or pain. For example, painful stimulus causes a significant decline of perfusion index.
As another example, a drug administration controller may be responsive to a cycle of transient desaturations over a limited timeframe, such as indicated by Desat Index, described above. Patients receiving pain medication may be predisposed to respiratory depression. If the patient has an underlying respiratory condition, pain medication may cause the patient to spiral into a cascade of cyclic desaturations, which initially are mild but may worsen quickly, leading to respiratory depression and even arrest.
As a further example, a drug administration controller may be responsive to respiration rate (RR) monitoring, as described above. RR provides an accurate marker for indicating acute respiratory dysfunction. For example, during conscious sedation, there is a risk of respiratory depression, and changes in RR typically provide an earlier warning than does pulse oximetry alone.
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In one embodiment, sensors 106 include a pulse oximetry sensor, such as described in U.S. Pat. No. 5,782,757 entitled Low Noise Optical Probes and physiological measurement devices 108 include a pulse oximeter, such as described in U.S. Pat. No. 5,632,272 entitled Signal Processing Apparatus, both assigned to Masimo Corporation, Irvine, Calif. and both incorporated by reference herein. In another embodiment, sensors 106 and measurement devices 108 include a multiple wavelength sensor and a corresponding noninvasive blood parameter monitor, such as the RAD-57™ and Radical-7™ for measuring SpO2, CO, HbMet, pulse rate, perfusion index and signal quality. The RAD-57 and Radical-7 are available from Masimo Corporation, Irvine, Calif. In other embodiments, sensors 106 also include any of LNOP® adhesive or reusable sensors, SofTouch™ sensors, Hi-Fi Trauma™ or Blue™ sensor all available from Masimo Corporation, Irvine, Calif. Further, measurement devices 108 also include any of Radical®, SatShare™, Rad-9™, Rad-5™, Rad-5v™ or PPO+™ Masimo SET® pulse oximeters all available from Masimo Corporation, Irvine, Calif.
In a particular embodiment, the control or monitor outputs 102 or both are responsive to a Desat Index or a PI Delta or both, as described above. In another particular embodiment, one or more of the measurement devices 108, the parameter processor 101 and the drug administrative device 104 are incorporated within a single unit. For example, the devices may be incorporated within a single housing, or the devices may be separately housed but physically and proximately connected.
Although sensors 106 are described above with respect to noninvasive technologies, sensors 106 may be invasive or noninvasive. Invasive measurements may require a person to prepare a blood or tissue sample, which is then processed by a physiological measurement device.
In one embodiment, the administered drug is a nitrate, such as sodium nitroprusside, and the blood parameter monitored is HbMet. In a particular embodiment, the blood parameter monitor 208 provides a control output according to one or more entries in TABLE 1. In another particular embodiment, the blood parameter monitor 208 provides a control output according to one or more entries in TABLE 2. In yet another embodiment, a blood parameter monitor 208 confirms that the measurement of HbMet is accurate, such as by checking a signal quality parameter or by having multiple sensors 206 on the patient 1.
Another embodiment involves patient controlled analgesia (PCA), i.e. the administered drug is an analgesia, and administration of the drug is controlled by the patient according to perceived pain levels. Analgesia administration, however, is paused in response to one or more blood parameters and corresponding metrics. In one embodiment, the blood parameter monitored is SpO2 and the blood parameter monitor 208 provides a control output responsive to Desat Index. In a particular embodiment, PCA is paused or disabled according to TABLE 3.
In another embodiment, the blood parameter monitor 208 provides a control output responsive to a PI indication of pain. In this manner, the administration of anesthesia is controlled according to the patient's perceived pain level. In a particular embodiment, PCA is paused or enabled according to one or more entries of TABLE 4, where a falling PI results in a negative PI Delta relative to an established baseline.
In one embodiment, the administered medical gas is a NO, and the blood parameter monitored is HbMet. In a particular embodiment, the blood parameter monitor 308 provides a control output according to one or more entries of TABLE 6. In another particular embodiment, the blood parameter monitor 308 provides a control output according to one or more entries of TABLE 7. In yet another embodiment, a blood parameter monitor 308 confirms that the measurement of HbMet is accurate, such as by checking a signal quality parameter or by having multiple sensors 306 on the patient 1. In a further embodiment, the administered medical gas is CO, and the blood parameter monitored is HbCO.
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User I/O 60, external devices 70 and wireless communication 80 also interface with the parameter processor 101 and provide communications to the outside world. User I/O 60 allows manual data entry and control. For example, a menu-driven operator display may be provided to allow entry of predetermined alarm thresholds. External devices 70 may include PCs and network interfaces to name a few.
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A drug administration controller has been disclosed in detail in connection with various embodiments. These embodiments are disclosed by way of examples only and are not to limit the scope of the claims that follow. One of ordinary skill in art will appreciate many variations and modifications.
Claims
1. A drug administration method comprising:
- measuring at least one physiological parameter with a noninvasive optical sensor attached to a patient;
- deriving at least one parameter trend for each measured physiological parameter, the trend indicating if the at least one parameter for each measured physiological parameter is increasing or decreasing at a certain rate over a certain time; and
- controlling a drug administration device based at least on one of the at least one parameter trends,
- wherein the at least one physiological parameter includes perfusion index.
2. The drug administration method according to claim 1 further comprising deriving at least one parameter limit, parameter pattern and a parameter variability.
3. The drug administration method according to claim 1 wherein controlling comprises enabling the drug administration device when perfusion index is trending downward as a marker of pain stimulus.
4. The drug administration method according to claim 1 wherein controlling further comprises pausing the drug administration device when perfusion index is not trending downward.
5. The drug administration method according to claim 1 wherein the at least one physiological parameter includes HbMet and wherein controlling comprises pausing the drug administration device when HbMet is trending upward.
6. The drug administration method according to claim 1 further comprising deriving a parameter limit and wherein the at least one physiological parameter includes HbMet and controlling comprises pausing the drug administration device when HbMet is above HbMet limit.
7. The drug administration method according to claim 1 comprising measuring respiration rate with a noninvasive sensor attached to a patient and deriving a respiration rate trend, wherein controlling comprises pausing the drug administration device when said RR trend is trending downward.
8. The drug administration method according to claim 1 comprising measuring RR with a noninvasive sensor attached to a patient wherein controlling comprises pausing the drug administration device when respiration rate is less than a respiration rate limit.
9. The drug administration method according to claim 1 wherein the at least one physiological parameter includes HbCO.
10. The drug administration method according to claim 1 comprising measuring oxygen saturation with a noninvasive sensor attached to a patient wherein controlling comprises pausing the drug administration device when a number of cyclical desaturations over a given timeframe is greater than a predetermined threshold.
11. A drug administration controller comprising:
- at least one noninvasive optical sensor that generates at least one sensor signal in response to a physiological state of a living being;
- at least one physiological measurement device that generates measurements of at least one physiological parameter in response to the at least one sensor signal, said at least one physiological parameter including perfusion index;
- a rules-based processor that generates a control output in response to at least trends of the physiological parameter measurements, the trends indicating if the physiological parameter measurements are increasing or decreasing at a certain rate over a certain time; and
- a drug administration device responsive to one or more control outputs so as to affect the treatment of the living being including at least one of initiating, pausing, halting or adjusting the dosage of administered drugs.
12. The drug administration controller according to claim 11 wherein the drug administration device is one of a drug infusion device and a medical gas inhalation device.
13. The drug administration controller according to claim 12 wherein the at least one sensor comprises:
- the optical; and
- a sound sensor attached proximate to a neck site so as to measure respiration rate.
14. The drug administration controller according to claim 11 wherein the at least one blood parameter comprises at least one of HbMet and HbCO.
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Type: Grant
Filed: Jan 17, 2007
Date of Patent: May 22, 2012
Assignee: MASIMO Corporation (Irvine, CA)
Inventor: Massi E. Kiani (Laguna Niguel, CA)
Primary Examiner: Kevin C Sirmons
Assistant Examiner: Bradley Thomas, Jr.
Attorney: Knobbe Martens Olson & Bear LLP
Application Number: 11/654,904
International Classification: A61M 1/00 (20060101); A61M 31/00 (20060101); A61M 37/00 (20060101);